A Study in Participants With Rheumatoid Arthritis



Status:Terminated
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:5/16/2018
Start Date:January 2011
End Date:January 2014

Use our guide to learn which trials are right for you!

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-α Inhibitors (FLEX V)

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the
treatment of rheumatoid arthritis in participants with an inadequate response to one or more
tumor necrosis factor-alpha (TNF-α) inhibitors.

This study is comprised of 2 periods:

Period 1: 24-week blinded treatment

Period 2: 48-week post-treatment follow-up


Inclusion Criteria:

- Diagnosis of RA of more than 6 months and less than 15 years

- At least 8 tender and swollen joints

- An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate
(ESR)

- Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP)
antibody

- Previously treated with biologic TNF-α inhibitor therapy (infliximab, certolizumab,
golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy
or intolerance

- Regular use of at least 1 conventional disease-modifying anti-rheumatic drug (DMARD),
with a stable dose for at least 8 weeks prior to study start

- Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion Criteria:

- Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6
weeks

- Steroid injection or intravenous (IV) infusion in the last 6 weeks

- Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks

- History of a serious reaction to other biological DMARDs

- Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the
last 8 weeks

- Surgery on a joint or other major surgery less than 2 months ago, or plans to have
joint surgery or major surgery during the study

- Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,
ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition
except RA

- Cervical cancer or squamous skin cancer within the past 3 years, or other cancer
within the past 5 years

- Received a live vaccine received within the past 12 weeks (for example, vaccines for
measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)

- Hepatitis or human immunodeficiency virus (HIV)

- A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months
or a serious bone or joint infection within 6 months

- Symptoms of herpes zoster or herpes simplex within the last month

- Active or latent tuberculosis (TB)

- Current symptoms of a serious disorder or illness

- Use of an investigational drug within the last month
We found this trial at
111
sites
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
1333
mi
from 43215
Albuquerque, NM
Click here to add this to my saved trials
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
1069
mi
from 43215
Austin, TX
Click here to add this to my saved trials
981
mi
from 43215
Aventura, FL
Click here to add this to my saved trials
Berkeley Heights, New Jersey 07922
455
mi
from 43215
Berkeley Heights, NJ
Click here to add this to my saved trials
405
mi
from 43215
Bethlehem, PA
Click here to add this to my saved trials
492
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
1006
mi
from 43215
Bismarck, ND
Click here to add this to my saved trials
955
mi
from 43215
Boca Raton, FL
Click here to add this to my saved trials
276
mi
from 43215
Bowling Green, KY
Click here to add this to my saved trials
943
mi
from 43215
Boynton Beach, FL
Click here to add this to my saved trials
478
mi
from 43215
Brooklyn, NY
Click here to add this to my saved trials
179
mi
from 43215
Brownsburg, IN
Click here to add this to my saved trials
5386
mi
from 43215
Buenos Aires,
Click here to add this to my saved trials
590
mi
from 43215
Burlington, VT
Click here to add this to my saved trials
396
mi
from 43215
Cape Girardeau, MO
Click here to add this to my saved trials
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
428
mi
from 43215
Chesapeake, VA
Click here to add this to my saved trials
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
Clarksburg, West Virginia 26301
150
mi
from 43215
Clarksburg, WV
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
470
mi
from 43215
Clifton, NJ
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
1161
mi
from 43215
Colorado Springs, CO
Click here to add this to my saved trials
426
mi
from 43215
Columbia, SC
Click here to add this to my saved trials
303
mi
from 43215
Danville, VA
Click here to add this to my saved trials
772
mi
from 43215
Debary, FL
Click here to add this to my saved trials
430
mi
from 43215
Decatur, GA
Click here to add this to my saved trials
1162
mi
from 43215
Denver, CO
Click here to add this to my saved trials
422
mi
from 43215
Dunwoody, GA
Click here to add this to my saved trials
1723
mi
from 43215
Eagle, ID
Click here to add this to my saved trials
624
mi
from 43215
Edina, MN
Click here to add this to my saved trials
212
mi
from 43215
Erie, PA
Click here to add this to my saved trials
1935
mi
from 43215
Escondido, CA
Click here to add this to my saved trials
280
mi
from 43215
Evansville, IN
Click here to add this to my saved trials
398
mi
from 43215
Florissant, MO
Click here to add this to my saved trials
660
mi
from 43215
Flowood, MS
Click here to add this to my saved trials
1993
mi
from 43215
Fresno, CA
Click here to add this to my saved trials
393
mi
from 43215
Gainesville, GA
Click here to add this to my saved trials
Greensboro, North Carolina 27401
321
mi
from 43215
Greensboro, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
358
mi
from 43215
Greenville, SC
Click here to add this to my saved trials
351
mi
from 43215
Greer, SC
Click here to add this to my saved trials
648
mi
from 43215
Haverhill, MA
Click here to add this to my saved trials
1913
mi
from 43215
Hemet, CA
Click here to add this to my saved trials
304
mi
from 43215
Hickory, NC
Click here to add this to my saved trials
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92646
1967
mi
from 43215
Huntington Beach, CA
Click here to add this to my saved trials
410
mi
from 43215
Huntsville, AL
Click here to add this to my saved trials
1508
mi
from 43215
Idaho Falls, ID
Click here to add this to my saved trials
166
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
660
mi
from 43215
Jackson, MS
Click here to add this to my saved trials
506
mi
from 43215
Jonesboro, AR
Click here to add this to my saved trials
1640
mi
from 43215
Kalispell, MT
Click here to add this to my saved trials
620
mi
from 43215
Kansas City, KS
Click here to add this to my saved trials
283
mi
from 43215
Knoxville, TN
Click here to add this to my saved trials
1942
mi
from 43215
La Mesa, CA
Click here to add this to my saved trials
1767
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
429
mi
from 43215
Lewes, DE
Click here to add this to my saved trials
154
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
395
mi
from 43215
Limerick, PA
Click here to add this to my saved trials
622
mi
from 43215
Little Rock, AR
Click here to add this to my saved trials
1919
mi
from 43215
Loma Linda, CA
Click here to add this to my saved trials
1975
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
1130
mi
from 43215
Lubbock, TX
Click here to add this to my saved trials
425
mi
from 43215
Marietta, GA
Click here to add this to my saved trials
508
mi
from 43215
Memphis, TN
Click here to add this to my saved trials
902
mi
from 43215
Mesquite, TX
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
335
mi
from 43215
Milwaukee, WI
Click here to add this to my saved trials
721
mi
from 43215
Monroe, LA
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
487
mi
from 43215
Myrtle Beach, SC
Click here to add this to my saved trials
629
mi
from 43215
Nashua, NH
Click here to add this to my saved trials
331
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
810
mi
from 43215
New Port Richey, FL
Click here to add this to my saved trials
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
266
mi
from 43215
Owensboro, KY
Click here to add this to my saved trials
821
mi
from 43215
Palm Harbor, FL
Click here to add this to my saved trials
1653
mi
from 43215
Paradise Valley, AZ
Click here to add this to my saved trials
348
mi
from 43215
Peoria, IL
Click here to add this to my saved trials
1662
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
837
mi
from 43215
Pinellas Park, FL
Click here to add this to my saved trials
311
mi
from 43215
Racine, WI
Click here to add this to my saved trials
341
mi
from 43215
Richmond, VA
Click here to add this to my saved trials
408
mi
from 43215
Rock Island, IL
Click here to add this to my saved trials
175
mi
from 43215
Saint Clair Shores, MI
Click here to add this to my saved trials
394
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
374
mi
from 43215
Sanford, NC
Click here to add this to my saved trials
1985
mi
from 43215
Santa Monica, CA
Click here to add this to my saved trials
1653
mi
from 43215
Scottsdale, AZ
Click here to add this to my saved trials
1778
mi
from 43215
Spokane, WA
Click here to add this to my saved trials
448
mi
from 43215
Stockbridge, GA
Click here to add this to my saved trials
1007
mi
from 43215
Sugar Land, TX
Click here to add this to my saved trials
2012
mi
from 43215
Tacoma, WA
Click here to add this to my saved trials
963
mi
from 43215
Tamarac, FL
Click here to add this to my saved trials
831
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
349
mi
from 43215
Taylors, SC
Click here to add this to my saved trials
1983
mi
from 43215
Torrance, CA
Click here to add this to my saved trials
752
mi
from 43215
Tulsa, OK
Click here to add this to my saved trials
1958
mi
from 43215
Tustin, CA
Click here to add this to my saved trials